MOLOGEN AG: Results of the Extension Phase of the Exploratory Phase Ib/IIa Study in HIV

The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200;
Frankfurt Stock Exchange Prime Standard: MGN) announced the key results
of the extension phase of the exploratory phase Ib/IIa TEACH trial to
evaluate lefitolimod in HIV-positive (HIV: human immunodeficiency virus)
patients on antiretroviral therapy (ART).The study, a
cooperation with the Aarhus University Hospital in Denmark, was extended
based on the positive results seen in the initial study phase as
recently published1. Findings from the
extension phase of TEACH suggest – although lefitolimod alone on top of
ART did not show the desired effect on the viral reservoir – the
compound could be an important combination partner for other
interventions aiming at HIV cure, such as monoclonal antibodies or
vaccines.

This conclusion is supported by the main following study results:

Sustained increases in activation of important immune cells (CD4 and
CD8 T cells) were observed throughout the dosing period of 24 weeks.

After interruption of ART, one of the nine patients who participated
in that study part showed viral control for more than 20 weeks,
whereas the interval until viral rebound is generally two weeks.

The intervention had no detectable effects on the size of viral
reservoir in peripheral blood in the total study population of 12
patients, which was defined as the primary endpoint of the extension
phase of the study.

24 weeks of lefitolimod treatment was safe and well tolerated in HIV
patients on ART, corroborating the favourable safety profile already
seen in cancer patients.

“The available T and B cell data together with its excellent safety
profile suggest that lefitolimod could be very well suited to be
combined with other promising HIV cure interventions such as monoclonal
antibodies or an HIV vaccine. Such a combination trial has recently been
funded and is expected to start in 2018 as a collaboration between
MOLOGEN, Aarhus University Hospital and other international partners.
Furthermore, the finding that one patient controlled viral replication
to below the limit of detection and remained off ART for 22 weeks is
very intriguing and is currently under intensive evaluation”, said Ole
Schmeltz Søgaard, MD, PhD, Associate Professor at the Aarhus University
Hospital and principal investigator of the study, Department of
Infectious Diseases, Aarhus, Denmark.

The most common related adverse events in the extension phase of the
TEACH study were neutropenia, injection site reaction, fatigue,
dizziness, and headache. The majority of adverse events were of mild or
moderate intensity with no life-threatening or fatal events. There were
no discontinuations due to adverse events and no related serious adverse
events.

Dr Matthias Baumann, Chief Medical Officer of MOLOGEN AG commented:
“Lefitolimod on top of ART did not show the desired effect on the viral
reservoir. However, this study provides important positive findings with
regard to the effects of the reactivation of the immune system, also in
HIV. These data together with the favorable safety profile of
lefitolimod now confirmed also in HIV form the basis for our future
development strategy for lefitolimod in combination therapies. We are
confident that lefitolimod can be an important component of therapeutic
approaches aiming to cure HIV.”

A more extensive evaluation of the TEACH data is currently ongoing.
Detailed TEACH study results of the extension phase will be presented at
an international scientific conference.

MOLOGEN’s ongoing development programs, especially the pivotal IMPALA
study in the indication of colorectal cancer, are running independently
from these study results, given these are different indications.

TEACH (Toll-like receptor 9 enhancement of antiviral
immunity in chronic HIV infection) is a non-randomized
interventional phase Ib/IIa trial to evaluate lefitolimod in HIV
positive patients under antiretroviral therapy (ART). In the first part
of the study, 15 participants received four weeks of lefitolimod therapy
(60 mg s.c. twice weekly). The extension phase included 12 patients
under ART, who were treated for 24 weeks with lefitolimod. After
completion, nine of these patients participated in an analytical
antiretroviral treatment interruption (ATI) until viral rebound. ATI is
an established procedure used to determine the size and reduction of the
reservoir of latent infected cells which is measured via time to viral
rebound. After viral rebound ART is reintroduced.

Aarhus University Hospital, Denmark conducted the trial in two hospital
centers in Denmark for which it received funding from the American
Foundation for AIDS research (amfAR). MOLOGEN provided the Immune
Surveillance Reactivator (ISR) lefitolimod.

The primary endpoint of the first study treatment phase is the change in
proportions of activated natural killer cells in patients. Secondary
study endpoints include, among others, a collection of safety,
virological, immunological and pharmacodynamic data. In the extension
phase the change in HIV-DNA in circulating T cells was assessed as
primary endpoint. Main secondary endpoints were – besides safety
evaluation – changes of functional immune parameters.

HIV infects the immune system and destroys or affects the proper
function of immune cells. Without antiretroviral treatment, this
eventually leads to immune deficiency and the immune system can no
longer fend off a wide range of infections and diseases.

HIV remains a serious worldwide health issue. According to estimates by
WHO and UNAIDS (United Nations Programme on AIDS) 37 million people
worldwide were living with HIV at the end of 2014. Some 2 million people
became newly infected in that same year, and 1.2 million died as a
result of HIV-related causes globally.

MOLOGEN AG

As a biopharmaceutical company, MOLOGEN AG is considered a pioneer in
the field of immunotherapies on account of its unique compounds and
technologies. Alongside a focus on immuno-oncology, MOLOGEN develops
immunotherapeutic agents for the treatment of infectious diseases.

The immunotherapeutic agent lefitolimod is the company’s lead product
and the best-in-class TLR9 agonist. Treatment with lefitolimod triggers
a broad and strong activation of the immune system. On account of this
mode of action, lefitolimod is an immune surveillance reactivator (ISR)
and has the potential to be used in a variety of different indications.
At present, the ISR lefitolimod is being developed for first-line
maintenance treatment of colorectal cancer (pivotal study). The phase II
IMPULSE study shows positive results in two pre-defined and clinically
relevant subgroups of patients. A more extensive evaluation of the
IMPULSE data is currently ongoing. In addition, the ISR lefitolimod is
currently being investigated in an extended phase I trial in HIV and a
phase I combination study with the checkpoint inhibitor Yervoy® (ipilimumab).
Alongside checkpoint inhibitors, lefitolimod is one of the few product
candidates in the field of immuno-oncology that is close to market.
MOLOGEN’s pipeline focuses on new innovative immunotherapies to treat
diseases for which there is great medical demand.

Certain statements in this communication contain formulations or
terms referring to the future or future developments, as well as
negations of such formulations or terms, or similar terminology. These
are described as forward-looking statements. In addition, all
information in this communication regarding planned or future results of
business segments, financial indicators, developments of the financial
situation or other financial or statistical data contains such
forward-looking statements. The company cautions prospective investors
not to rely on such forward-looking statements as certain prognoses of
actual future events and developments. The company is neither
responsible nor liable for updating such information, which only
represents the state of affairs on the day of publication.

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